Brazil is the largest healthcare market in Latin America and spends 9.1 percent of its GDP in healthcare. Of the approximately 6,400 hospitals, 70 percent are private. There are approximately 495,000 hospital beds, 96,000 healthcare supplementary services, 432,000 physicians, 144,000 dentists and 70,000 drugstores.
An aging population and poor management of resources in the healthcare sector offer opportunities for U.S. products and services.
U.S. healthcare products must follow regulations established by the Brazilian Health Regulatory Agency (ANVISA). While certain low risk products may be exempt from registration, it is mandatory to have an importer or distributor for product liability. Also, it is recommended that foreign companies have local technical staff and replacement parts for customer support.
In Brazil, the healthcare market is price-driven, mostly towards products that are manufactured in country. Quality is also important and companies must meet all sanitary registration requirements to sell to the Government. U.S. companies should consider cost-saving concepts and make clear the benefits of new technologies in marketing and promotional materials.
Pharmaceuticals and Nutritional Supplements
Brazil ranks among the top six markets in size for drugs and pharmaceuticals with sales of $28.4 billion in 2018 including taxes (Source: Sindusfarma). In 2018, Brazil increased imports by 9.7 percent in medicines and raw materials, reaching $7.2 billion. For high value-added medicines, the United States and Europe are the main exporters to Brazil, while China, India, and Ireland are the main suppliers of raw ingredients.
Regulations prohibit sales of medicines and medical devices outside of specialized medical stores or pharmacies.
The GOB is the main buyer of healthcare products to supply the public healthcare system. U.S. companies can participate in bids as long they have local representatives, with some exceptions. It is also possible to participate in a Productive Development Partnership (PDP). PDPs are designed to allow international companies to partner with local laboratories to supply the public system for a period of up to five years, with a reserved market share, and with the goal of technology transfer at the end of the contract.
Companies should be well-prepared and fully investigate all terms before committing to a PDP.
In 2018, a new decree from ANVISA adjusted limits for daily intake, labeling, claims, and new products in the nutritional supplements and vitamins categories.
E-commerce is a growing channel for end-users to acquire imported products, if they are for personal use. To reduce returns, sellers should inform customers that Brazilian Customs charges fees to clear imported goods.
Leading areas of opportunities include: chronic diseases, e.g. blood pressure, diabetes, cardio, contraceptives, rare diseases, generic drugs; and infectious diseases, e.g. HIV and Hepatitis C, weight loss, vitamins and sports nutrition.
Medical Devices/Health IT
For medical devices, the market size is approximately $10.5 billion. The consumption of healthcare products increased 13.3 percent in 2018. (Source: Abimed)
In 2018, Brazil increased imports of medical devices 21.8 percent, reaching $5.4 billion. Imported medical devices hold 80 percent of the market in Brazil and the United States represents 29 percent of this share. Brazil is the 14th largest market for U.S. medical devices and second in Latin America, after Mexico. In 2018, U.S. medical device exports to Brazil reached $953 million, an increase of 9.6 percent from the previous year. (Source: Census Bureau, U.S. Department of Commerce (DOC).
Brazil is part of the Medical Devices Single Audit Program (MDSAP), in conjunction with the United States, Japan, Canada, and Australia. This can expedite processes of approval for new products in Brazil, though ANVISA maintains their fee in addition to the MDSAP fees.
For Healthcare IT, the Ministry of Health announced possible investments of more than $450 million by 2019 to digitalize the public basic care units of the country’s Unified Health System (SUS). Private hospitals are also investing in technology, and several new hospitals are formalizing their progress by obtaining international certificates for data management and reduction of paper use. The Federal Council of Medicine is in discussion to regulate the market for Telemedicine, which could open opportunities for U.S. companies to deliver solutions for teleconsultation, telediagnostic and data safety.
Brazilian hospitals are also investing in minimally invasive technology for complex procedures, such as stents and catheters. One source also reported that by 2018, there were 41 types of equipment for robotic surgery in the country.
U.S. companies can be competitive in the Brazilian market when offering high quality, innovative products at a competitive price.